Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma

Korábbi kezelés

• Has received prior systemic anti-cancer therapy including investigational agents within the prior 2 weeks.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.

Laborértékek

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, Cluster of Differentiation 137 (CD137)).

Egyéb

• Has a contraindication to tissue biopsy for minimally invasive research-procedure.
• Contraindication to phlebotomy (up to 40 milliliters (mL)) per phlebotomy every three weeks).

• Participants must have histologically confirmed locally advanced or metastatic melanoma and be starting on standard of care pembrolizumab monotherapy. Participants may have received any or no prior anti-cancer therapy without limitation.
• Must have one or more sites of disease amenable to biopsy (tumor, skin, lymph node, pleural fluid, peritoneal fluid, cerebral spinal fluid (CSF)).
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Participants must be age 18 years or older on the day of signing informed consent.
• Have the ability to provide written informed consent for the trial.
• Be able and willing to comply with study procedures including provision of basic demographic information and medical history.
• Be willing to receive periodic follow up phone calls to monitor health status and survival status.